Faridoxorubicin

LONDON and PHILADELPHIA, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a clinical stage biopharmaceutical company developing pre|CISION ® , a tumor-activated oncology delivery platform, has published a trading update for the year ended December 31, 2025. The Company made excellent progress during 2025, developing its unique industry-leading technology platform, pre|CISION ® , with two programs anticipated to be in clinical development in 2026. The Company raised £22.5m in equity during 2025 to support the investment in its programs. Highlights Research and Development Faridoxorubicin (AVA6000) program In December 2025 Avacta reported highly encouraging efficacy and safety data from the cohort of patients enrolled with salivary gland cancer where a disease control rate of 90% is maintained in the full cohort ( link ) Program continued to enroll patients in the Phase 1b expansion cohorts, to assess the efficacy of faridoxorubicin in more homogenous, defined patient populations to better predict the magnitude of efficacy anticipated in larger Phase 2/3 trials. FAP-Exd (AVA6103) program In December 2025 Avacta reported new pharmacology data in support of the IND process and the design of the Phase 1 trial was published in parallel ( link ) Clinical testing expected to initiate in Q1 2026, subject to clearance by regulators. Multiple U.S. specialty oncology centers are expected to open with key investigators of different specialties to enroll the four selected tumor types: pancreatic cancer, gastric cancer, small cell lung cancer and cervical cancer. Intellectual property (IP) portfolio continued to grow and gain momentum measured by increased IP filings. These include two important advances in the pre|CISION ® IP estate: the sustained release mechanism of payload delivery, piloted in the AVA6103 program, which is anticipated to begin clinical testing in Q1 2026; and the dual payload mechanism of delivery allowing the precise delivery of two payloads to the tumor with all of the benefits of the pre|CISION ® technology. Financial The Company successfully raised £22.5m in new equity during 2025 from a broad range of existing and new investors to support R&D programs and also renegotiated the terms of the convertible bond ( link ) Unaudited cash and cash equivalents as of December 31, 2025: £16.9m providing a runway into Q3 2026 supporting the planned spend on the Group’s two clinical stage programs and preclinical pipeline to key value inflection points. Outlook for 2026 Faridoxorubicin (AVA6000) program. Multiple data updates in both patient groups, with salivary gland cancers and with triple negative breast cancer updates expected in H1 2026. Beginning of the FAP-Exd (AVA6103) clinical testing expected in Q1 2026. A group of U.S. clinical trial specialty centers are expected to open imminently with key investigators of different specialties to enroll the four selected tumor types: pancreatic cancer, gastric cancer, small cell lung cancer and cervical cancer. Preliminary data from this trial is anticipated in the second half of 2026. Continued active interaction with potential partners regarding both faridoxorubicin (AVA6000) and FAP-Exd (AVA6103). The survival data in the SGC indication continues to mature, allowing planning of the next stage of development with potential partners ( link ). The initiation of the FAP-Exd clinical trial continues to be of interest in the market. Christina Coughlin MD, PhD, CEO of Avacta, commented : "We gained real traction with our R&D programs, based on our unique industry leading technology, pre|CISION ® , during 2025. There are no other technologies that can deliver cancer treatment drugs directly into the tumor at the concentrations that our payloads enable without causing highly toxic side effects. “Our sustained release mechanism piloted in the FAP-Exd (AVA6103) program is anticipated to begin clinical testing this quarter, a significant milestone achievement, just 24 months after the beginning of the program. This program continues to garner significant interest from global pharmaceutical companies; however, the Company’s strategy remains to retain 100% of AVA6103 until we begin to see readouts from the Phase 1a clinical trial. Importantly, the trial has been designed to rapidly deliver clinical data in this program. “We are developing further IP around the pre|CISION ® platform. Drug development isn’t just about science, it is about strategy and protecting our innovation. Our IP estate is the most valuable asset we have. To further this IP estate, we also raised over £22m to support our research and development programs, which gives us a runway into Q3 2026. These funds allow the Company to initiate the AVA6103 clinical trial and we anticipate the initial data in the AVA6103 program in the second half of 2026. “The unique nature of the dual payload program is also generating interest and we are exploring opportunities with multiple potential partners with a view to investigating the wide utility of this novel technology. “We continue to have multiple conversations with global pharmaceutical companies regarding our full pipeline. We are incredibly excited for the year ahead, which the board believes will be a transformative period for the Company, patients and our shareholders.” Operational update Faridoxorubicin (AVA6000) Highly encouraging data were presented last month describing the efficacy observed in the patients treated in the Phase 1b expansion cohort, which appears highly similar to the data observed in the Phase 1a patient population ( link ). The larger numbers of patients treated in this cohort are important to inform the design and size of a subsequent trial in this indication. Importantly, the prolonged PFS observed in the Phase 1a cohort of patients indicates a prolonged PFS in the Phase 1b cohort. Although these data can take time to collect, the Company is encouraged by the extended survival observations in the trial. Attention to this stage of development is designed to derisk later stages of clinical trials. The data in the Phase 1a portion of the trial were updated at ESMO ( link ), where the PFS was reported as highly encouraging when compared with benchmark data in this indication. As the data in the Phase 1b expansion cohort are preliminary, the Company continues to collect the data. The estimates of the PFS and overall survival (OS) will be used to design the randomized study in this indication. In addition, the Company expects to release data in the TNBC cohort in H1 2026. Further development of faridoxorubicin will be undertaken subject to a partner being secured. The Company continues to engage with multiple partners as the data matures. FAP-Exd (AVA6103) Recent pharmacology data ( link ) have been released demonstrating several key aspects of the FAP-Exd (AVA6103) program, including: Robust efficacy in a broad range of patient-derived cancer models with deep complete responses observed with only three doses of FAP-Exd, even in settings of low FAP expression. In an encouraging parallel, the durability of the responses in the preclinical setting with FAP-Exd match those observed among patients with salivary gland cancers, treated with faridoxorubicin even in the setting of low FAP expression ( link ). Tumor and plasma exposure studies have demonstrated that FAP-Exd rapidly penetrates the tumor microenvironment (TME), is held intact for over five days in the tumor and releases exatecan, with an observed high maximal concentration (C max ) in the tumor within minutes and very low exposure in the bloodstream which is undetectable within two hours. The FAP-Exd Phase 1 trial design has been released ( link ) and includes the following aspects to optimize the execution of this study: The trial will enroll patients with a selected set of four cancer indications predicted by AI (in our strategic collaboration with Tempus AI) to be the most sensitive among solid tumor indications. These include pancreatic cancer, small cell lung cancer, gastric cancer and cervical cancer. Importantly, each of these four disease settings has a favorable regulatory path forward and the group includes both large tumor types as well as potential orphan indications. Clinical trial sites in the U.S. and the trial investigators have been selected based on their deep experience with these indications. The Company has enjoyed strong interest among clinical trial sites and investigators in the study. The trial design has two key features to optimize the rapid collection of data: Two independent arms investigating two schedules with every two weeks dosing (Q2W) and every three weeks dosing (Q3W) are anticipated to enroll in parallel, and; The trial will use the Bayesian Optimal Interval (BOIN) design, a modern statistical method for oncology Phase 1 trials. BOIN combines the simplicity of the traditional 3+3 enrollment method, where small groups of patients are treated at increasing doses, with efficient dose exploration and flexible enrollment into cohorts to optimize data collection over the course of the trial. This approach has been shown to enable the trial to handle complex findings and rapidly identify the optimal dose range. Dual Payload Technology (AVA6207) The work in the AVA6103 program to better define the self-immolative linker technology led to the invention of the dual payload technology ( link ). The dual payload platform is enabled by the insertion of two payload attachment points in the linker, ensuring the independent release of both payloads with a single FAP cleavage event. The release of two payloads in one pre|CISION ® medicine has three key advantages: Combination therapy is the mainstay of how patients are treated in oncology. The challenge is the toxicities with each individual drug. With a single pre|CISION ® medicine, a simple monotherapy trial is needed and both payloads have the benefits of the pre|CISION ® technology: concentration in the TME and minimal exposure in normal tissues. The release of dual payloads is accomplished without the need for a biologic arm (e.g. an antibody, Fc region or Affimer) which greatly simplifies the manufacturing of these medicines. Indeed, all pre|CISION ® medicines are small molecules, meaning short and chemical-based manufacturing that is more cost-efficient than biologics. Because the size of the molecule is small, rapid and efficient tumor penetration of two payloads is anticipated based on the data presented with FAP-Exd, where tumor cells will see both payloads in parallel. The design of the first program combines a topoisomerase I inhibitor with a second payload that can overcome a key resistance mechanism, namely the DNA Damage Repair pathway (DDR). Preclinical data presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (October, 2025) demonstrates preliminary synergy of this combination ( link ). The Company has committed to the selection of the payloads for the AVA6207 program in 2026. Financial update The Company raised £22.5m in equity (gross) to support its investment programs during the year and also realized just over £15m from the disposal of the non-core diagnostics businesses. The Company renegotiated the terms of the convertible bond with the Quarterly Convertible Bond repayments and interest in January 2026 and April 2026 payment dates deferred until October 2027. In addition, the bondholder has the right to accelerate the satisfaction of the deferred repayments based on agreed conditions and the conversion price of the convertible bond is reset at 75.0p. All conditions of the bond renegotiation are reported here ( link ). Unaudited cash and cash equivalents at as December 31, 2025, were £16.9m, providing the Company with a runway into Q3 2026 to support its research and development activities. For further information from Avacta, please contact: Avacta Group plc Christina Coughlin, Chief Executive Officer via ICR Healthcare Strand Hanson Limited (Nominated Adviser) James Harris / Chris Raggett / James Dance Zeus (Broker) James Hornigold / George Duxberry / Dominic King ICR Healthcare Mary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@consilium-comms.com Investor Contact Renee Leck THRUST Strategic Communications renee@thrustsc.com Media Contact Carly Scaduto THRUST Strategic Communications carly@thrustsc.com About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION ® platform. pre|CISION ® is a proprietary payload delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION ® peptide drug conjugates (PDC) or Affimer ® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. The pre|CISION ® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION ® platform harnesses this tumor specific protease to cleave pre|CISION ® peptide drug conjugates and pre|CISION ® antibody/Affimer ® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.

Preliminary Phase 1b data is in line with Phase 1a data reported at the European Society of Medical Oncology in September 2025 Combined disease control rate of 90% across both Phase 1a and Phase 1b patients with confirmed partial and minor responses observed LONDON and PHILADELPHIA, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a clinical stage biopharmaceutical company developing pre|CISION®, a tumor-activated oncology delivery platform, today announced compelling new data in patients with salivary gland cancer (SGC) enrolled in the ongoing Phase 1b trial of faridoxorubicin (AVA6000). The data show confirmed partial and minor responses, consistent with data previously reported from the Phase 1a part of the study. Faridoxorubicin is the first peptide drug conjugate (PDC) in Avacta’s pipeline. It consists of doxorubicin conjugated with Avacta’s proprietary pre|CISION® peptide and is specifically cleaved (released) by fibroblast activation protein-alpha (FAP), which is over-expressed in the tumor microenvironment, enabling targeted release of the doxorubicin payload. SGC accounts for 6-8% of head and neck cancers, with approximately 2,500 cases diagnosed in the U.S. each year.1 SGC is a disease that does not respond to chemotherapy, has no standard therapy defined in the metastatic setting and a five-year survival rate of approximately 42%2 in advanced stage disease. Avacta’s recent data demonstrate continued robust and meaningful tumor shrinkage in patients with SGCs and a combined disease control rate of 90% across Phase 1a and Phase 1b patients. Based on the preliminary favorable efficacy and safety data observed in the Phase 1b cohort in this part of the trial, enrollment will continue in this cohort with further data updates across the Phase 1a and Phase 1b cohorts expected in 1H 2026. Christina Coughlin MD, PhD, CEO of Avacta, commented: "These data continue to reinforce our belief in the transformative potential of our pre|CISION® peptide drug conjugates to expand the therapeutic index and increase the efficacy of highly potent therapeutics and further strengthens our confidence across our broader pipeline. “SGC cancer is a devastating disease with no established standard of care treatment options. The clinically meaningful tumor shrinkage and prolonged progression free survival we have observed in the study highlight faridoxorubicin’s potential as an important new treatment option for patients with SGC and other solid tumors. The Phase 1b data will mature as we continue to collect the survival data in this cohort. “Translational data collected from this population continue to demonstrate the power of our pre|CISION® platform, with optimal payload release observed even at the lowest levels of FAP expression. This supports a broad market opportunity for all pre|CISION® medicines across our pipeline.” Faridoxorubicin (AVA6000) - Clinical data observations in SGCThese data demonstrate ongoing evidence of durable anti-tumor activity in patients with SGC (both treatment-naïve and those who have failed earlier lines of therapy), that is supported by ongoing RECIST3 responses (both partial and minor responses) and continued observation of a robust disease control rate and strong progression-free survival (PFS) data. The trial enrolled both a Phase 1a cohort (n=11) and Phase 1b cohort to date (n=19 evaluable for efficacy) for a total of 30 patients with SGC. Of the 30 patients with SGC treated at the dose of 250 mg/m2 and above and evaluable for efficacy, nine experienced clinically meaningful disease shrinkage, including two confirmed partial responses (PR, >30% tumor shrinkage) and seven minor responses (MR, >10% and <30% tumor shrinkage) using RECISTv1.1 criteria. PFS in the Phase 1b cohort has not been reached with a median follow up exceeding 15 weeks at the data cutoff. These data include the following: Nineteen patients in the Phase 1b arm of the trial are evaluable for efficacy. Safety findings (n=22) are in line with those data reported in the Phase 1a cohort. Three patients enrolled were not evaluable for efficacy at the data cutoff (2 patients not eligible and 1 patient not having reached an initial follow up scan) but having received one dose of drug are considered evaluable for safetyThe baseline characteristics of the patients enrolled in the Phase 1b are in line with the patients in Phase 1a. In Phase 1b, the median number of prior therapy regimens in the metastatic setting is 1 with a range of 0-2. Seven patients in Phase 1b had not received prior systemic therapyAmong the total of 30 patients evaluable for efficacy treated at the dose of 250 mg/m2 and above in Phase 1a and 1b, 27 patients demonstrated partial or minor responses or stable disease, resulting in a disease control rate of 90% across the two arms in line with previously reported dataClinically meaningful tumor shrinkage was observed with two patients with confirmed partial responses and seven patients with confirmed minor responses (across Phase 1a and 1b)Median progression free survival in the cohort of 19 patients in the Phase 1b has not been reached. Thirteen of 19 patients remain on therapy and an additional two patients remain in PFS follow-up at the data cutoff Although the Phase 1b data are early in the treatment course of most patients, the emerging data are consistent with the previously reported Phase 1a observations with no diminution of activity observed in SGC. Faridoxorubicin continues to demonstrate the favorable safety profile and efficacy in SGC that has characterized it since its initial clinical evaluation. 1 Key Statistics in Salivary Gland Cancers (2025) | American Cancer Society. Available at: www.cancer.org/cancer/types/salivary-gland-cancer.html 2 Survival rates for salivary gland cancer: Salivary gland survival (2025) Salivary Gland Survival | American Cancer Society. Available at: https://www.cancer.org/cancer/types/salivary-gland-cancer/detection-diagnosis-staging/survival-rates.html 3 Reduction in the sum of longest diameters (SLD) is used to measure response per RECIST 1.1 with partial responses having at least a 30% reduction and minor responses of between >10% and <30% reduction. For further information from Avacta, please contact: Avacta Group plcChristina Coughlin, Chief Executive Officerhttps://avacta.com/ via ICR Healthcare Peel Hunt (Nomad and Broker)James Steel / Chris Golden / Ben Harriswww.peelhunt.com Zeus (Joint Broker)James Hornigold / George Duxberry / Dominic Kingwww.zeuscapital.co.uk ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbertavacta@icrhealthcare.com Investor ContactRenee Leck THRUST Strategic Communicationsrenee@thrustsc.com Media ContactCarly ScadutoTHRUST Strategic Communicationscarly@thrustsc.com About Avacta - www.avacta.com Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary payload delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. The pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.